Operation Calm is a single-arm, mixed-methods feasibility study evaluating a virtual reality (VR) nature-based mindfulness intervention with children and adolescents aged 6-17 years, parents, and clinicians. Children complete one guided mindfulness session combining an immersive 360° nature environment with breathing, sensory awareness, and grounding exercises. Parents and clinicians view the intervention through a secure online link. The study examines feasibility, acceptability, engagement, usability, perceived usefulness, and child tolerability. It also explores immediate changes in children's anxiety, calmness, state mindfulness, and nature connectedness. Feedback from children, parents, and clinicians will guide further refinement of Operation Calm before it is evaluated in a larger clinical study.
Aged 6-17 years
Able to understand English or French
Residing in Canada
Have access to a smartphone compatible with the YouTube application and the study's smartphone-compatible VR headset
Unable to safely or comfortably use the VR headset
Unable to view the intervention or complete the questionnaires
Unable to provide assent or consent, as applicable
Parent or legal guardian does not provide informed consent
Single group
Operation Calm EEMCF-VR
BehavioralOperation Calm is a virtual reality (VR) nature-based mindfulness intervention for children and adolescents aged 6-17 years. Children complete one brief immersive 360° nature experience paired with guided mindfulness exercises focused on paced breathing, grounding, sensory awareness, present-moment attention, and reflection on calm and safety. Each child is assigned one of five nature scenes and views the intervention using a smartphone-compatible VR headset. The intervention is designed to teach coping skills that may eventually support children facing medical or dental procedures. Parents and clinicians view the intervention through a secure online link and provide feedback. This is a single-arm feasibility study and does not include a control condition.
Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
Pediatric Simulator Sickness Questionnaire (Peds SSQ): A self-report questionnaire assessing simulator sickness symptoms following virtual reality exposure. Total scores range from 0 to 90, with higher scores indicating greater simulator sickness (worse tolerability).
Recruitment Rate
Percentage of individuals who enroll in the study among all individuals approached or responding to recruitment materials. Calculated as: number enrolled ÷ number approached or responding × 100. Unit of Measure: Percentage of individuals
Eligibility Rate
Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.
Consent Rate
Percentage of eligible individuals who provide informed consent or parental consent and child assent, as applicable. Calculated as: number consenting ÷ number eligible × 100.
Change in Current Anxiety
Children will rate their current anxiety using a visual scale ranging from 0 to 10, where 0 means "not anxious at all" and 10 means "extremely anxious." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change. This outcome is exploratory and will not be interpreted as evidence of clinical effectiveness.
Change in Current Calmness
Children will rate their current calmness using a visual scale ranging from 0 to 10, where 0 means "not calm at all" and 10 means "completely calm." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change.
Missing Questionnaire Data
Percentage of expected questionnaire items that are missing across all required study questionnaires. Calculated as: number of unanswered items ÷ total number of expected questionnaire items × 100.
Questionnaire Completion Rate
Percentage of participants who complete all required study questionnaires. Calculated as: number completing all required questionnaires ÷ number enrolled × 100.
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